CLASS III Drug recall · Reported 3 Nov 2021 · FDA Enforcement Report
Rizatriptan Benzoate Orally Disintegrating Tablets 5mg recalled
Macleods Pharma USA is recalling Rizatriptan Benzoate Orally Disintegrating Tablets 5mg ( Unit-Dose Tablets), distributed nationwide in the US. The recall was initiated on 18 Oct 2021 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0079-2022
- FDA event ID
- 88872
- Recalling firm
- Macleods Pharma USA, Princeton, NJ
- Brand
- Rizatriptan Benzoate
- Manufacturer
- Macleods Pharmaceuticals Limited
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 18 Oct 2021
- FDA classified
- 28 Oct 2021
- Reported
- 3 Nov 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 18 Oct 2021 | Recall initiated by company | |
| 28 Oct 2021 | Classified by FDA | +10 days |
| 3 Nov 2021 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Rizatriptan Benzoate Orally Disintegrating Tablets 5mg, 12 Tablets (2 x 6 Unit-Dose Tablets) Blister Packs, Rx only, Manufactured for: Macleods Pharma USA Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA, NDC 33342-093-41
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
Which lots are affected?
Lot #: BRL2102A, BRL2103A, exp. date 04/2025
Where was it sold?
Nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 88872This product is part of a recall event; the main page for the event is Rizatriptan Benzoate Film Coated Tablets, 10 mg recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Rizatriptan Benzoate Film Coated Tablets, 10 mg recalledRizatriptan | Macleods Pharma USA | Potency & Assay | Nationwide | |
| CLASS III | Rizatriptan Benzoate Orally Disintegrating Tablets 10mg recalledRizatriptan Benzoate | Macleods Pharma USA | Potency & Assay | Nationwide |
More recalls from Macleods Pharma USA
All 34| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Levothyroxine Sodium Tablets USP 150 mcg recalled by Macleods Pharma UsaLevothyroxine Sodium | Macleods Pharma USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Losartan Potassium and Hydrochlorothiazide Tablets recalledLosartan Potassium And Hydrochlorothiazide | Macleods Pharma USA | Foreign Material | Nationwide |
| Drug | CLASS III | Levofloxacin Tablets, USP 500 mg recalled by Macleods Pharma Usa | Macleods Pharma USA | Packaging Defects | Nationwide |
| Drug | CLASS II | Eszopiclone Tablets, USP 1 mg recalled by Macleods Pharma UsaEszopiclone | Macleods Pharma Usa | Packaging Defects | Nationwide |
| Drug | CLASS II | Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 recalledLosartan Potassium And Hydrochlorothiazide | Macleods Pharma Usa | Potency & Assay | Nationwide |
Other Rizatriptan Benzoate recalls
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Rizatriptan Benzoate Tablets recalled by Ascend LaboratoriesRizatriptan Benzoate | Ascend Laboratories | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Rizatriptan Benzoate Tablets recalled by Ascend LaboratoriesRizatriptan Benzoate | Ascend Laboratories | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Rizatriptan Benzoate Tablets USP, 10 mg, 18-Dose Tablets recalledRizatriptan Benzoate | Glenmark Pharmaceuticals Inc., USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Rizatriptan Benzoate Orally Disintegrating Tablets, USP 5mg recalledRizatriptan Benzoate | Glenmark Pharmaceuticals Inc., USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Rizatriptan Benzoate Tablets USP, 5mg, 18-Dose Tablets recalledRizatriptan Benzoate | Glenmark Pharmaceuticals Inc., USA | Nitrosamine Impurity | Nationwide |